BNT162b2 COVID-19 vaccine trial : Pfizer and BioNTech have advanced their BNT162b2 COVID-19 vaccine candidate into phase 2/3 clinical development to study the safety and efficacy of the nucleoside-modified messenger RNA (modRNA) candidate.

BNT162b2 is one of the four candidates developed by the two pharma companies as part of their BNT162 mRNA-based vaccine program against the SARS-CoV-2 virus that causes COVID-19.

Pfizer and BioNTech said that BNT162b2 was picked to be advanced into the late-stage clinical development following an extensive analysis of preclinical and clinical data from phase 1/2 clinical trials, and also after consultation with the US Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) and other regulators across the world.

Commenting on the BNT162b2 COVID-19 vaccine trial, Kathrin U. Jansen – Senior Vice President and Head of Vaccine Research & Development at Pfizer, said: “Our selection of the BNT162b2 vaccine candidate and its advancement into a Phase 2/3 study are the culmination of an extensive, collaborative and unprecedented R&D program involving Pfizer, BioNTech, clinical investigators, and study participants with a singular focus of developing a safe and effective COVID-19 RNA vaccine. The Phase 2/3 study protocol follows all the U.S. Food and Drug Administration (FDA) guidance on clinical trial design for COVID-19 vaccine studies.

“The initiation of the Phase 2/3 trial is a major step forward in our progress toward providing a potential vaccine to help fight the ongoing COVID-19 pandemic, and we look forward to generating additional data as the program progresses.”

The BNT162b2 COVID-19 vaccine candidate will be assessed at a 30 µg dose level in a 2 dose regimen across the world with the exception of China. The phase 2/3 COVID-19 vaccine trial will feature up to 30,000 participants, aged 18-85 years, which has started in the US, and is expected to include nearly 120 sites in other parts of the world.

The late-stage coronavirus vaccine clinical trial is designed as a 1:1 vaccine candidate to placebo, randomized, observer-blinded study for collecting safety, immune response, and efficacy data required for regulatory review. The primary endpoints of the BNT162b2 COVID-19 vaccine candidate phase 2/3 trial will be prevention of the infection in those who have not been contracted by SARS-CoV-2 prior to immunization, and prevention of COVID-19 irrespective of whether participants have previously been infected by the novel coronavirus.

Secondary endpoints of the coronavirus vaccine trial include the prevention of severe COVID-19 infection in those groups.

Recently, BNT162b2 was granted the fast track status by the US FDA. This vaccine candidate encodes an optimized SARS-CoV-2 full length spike glycoprotein (S), which according to the partners is the target of virus-neutralizing antibodies.

Ugur Sahin – CEO and Co-Founder of BioNTech, commenting on the BNT162b2 COVID-19 vaccine trial, said: “We selected BNT162b2 as our lead candidate for this Phase 2/3 trial upon diligent evaluation of the totality of the data generated so far. This decision reflects our primary goal to bring a well-tolerated, highly effective vaccine to the market as quickly as possible, while we will continue to evaluate our other vaccine candidates as part of a differentiated COVID-19 vaccine portfolio.

“Many steps have been taken towards this important milestone and we would like to thank all those involved for their extraordinary commitment.”

Earlier this month, Pfizer and BioNTech signed a $1.95 billion deal with the US government for supplying 100 million doses of the BNT162 COVID-19 vaccine candidate.